MAUDE Adverse Event Report: COOK INC C-FLEX DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
Information was provided that upon retrieval of the ureteral stent out of the patient, the stent broke off into 2 pieces.The surgeon had to rescope the patient to see if he could endoscopically retrieve the rest of the stent.The surgeon was able to grasp the rest of the stent and pull it out through the urethra.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), specifications, quality control and visual inspection was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: "complications of ureteral stent placement are documented.Use of this device should be based upon consideration of risk-benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures.", "improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.Angulation of the wire guide or stent should be avoided.¿ also, it states ¿do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Device failure analysis: a visual examination of photos noted two pieces were returned.A coil was returned measuring approximately 5 cm in length.A coil with body was returned measuring 13.4 cm and body from base of coil measured 9 cm in length.It is possible that user technique contributed to this event; however, based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
Information was provided that upon retrieval of the ureteral stent out of the patient, the stent broke off into 2 pieces.The surgeon had to rescope the patient to see if he could endoscopically retrieve the rest of the stent.The surgeon was able to grasp the rest of the stent and pull it out through the urethra.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: C-FLEX DOUBLE PIGTAIL URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5935610
• Report Number: 1820334-2016-00962
• Device Sequence Number: 16239542
• Product Code: FAD
• UDI-Device Identifier: 00827002146372
• UDI-Public: (01)00827002146372(17)180508(10)5869857
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 036310
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2016
• Supplement Report FDA Received Date: 11/23/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention